Chemical entities SHINE in the top 10 fastest-growing drugs of 2016

Global pharmaceutical companies are increasingly focusing on the development of new biologics. In fact, in 2016, nine out of the top 15 pharmaceutical drugs by sales were of biologic origin. This makes us wonder what the future holds for manufacturers specializing in drugs that originate from chemical synthesis.

This week, PharmaCompass continued its analysis of the top pharma drugs by sales to evaluate the drugs that registered large sales growth in 2016.

Please note that these are not the top-selling drugs, but are the top 10 drugs that registered the maximum growth in global sales over 2015.

Interestingly, things didn’t appear that bad for drugs originating from chemical synthesis — while the top two drugs on the list were biologics, the remaining originated from chemical synthesis.

Here’s a list of drugs that witnessed the largest sales growth in 2016:

1. Opdivo (nivolumab) – Bristol-Myers Squibb

2016 sales: US$ 3,774 million

2015 sales: US$ 942 million

Sales growth: US$ 2,832 million

First approved in 2014, Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda — also known as checkpoint inhibitors — continued to stay on track to be among the top 20 best-selling drugs in the world by 2020. They represent the hot new field of immunotherapy and are known to have given 90-year old Jimmy Carter (former President of the United States) hope in his fight against cancer.

With a sales growth of US$ 2.832 billion, Opdivo registered the highest sales growth of any single drug in 2016. However, Bristol-Myers Squibb received a nasty surprise last year when Opdivo did not demonstrate the desired slowdown in the progress of advanced lung cancer in a trial, as compared to conventional chemotherapy.

While Bristol-Myers’ stock price plunged on this news, Merck announced that not only did Keytruda succeed in a clinical trial as an initial treatment for advanced non-small cell lung cancer, but patients actually lived longer. Although Keytruda did not make it to our list of top 10 drugs by sales growth in 2016, it did register a sales increase of US$ 836 million, as its sales grew from US$ 566 million to US$ 1,402 million.

2. Humira (adalimumab) – AbbVie

2016 sales: US$ 16,078 million

2015 sales: US$ 14,012 million

Sales growth: US$ 2,066 million

Abbvie’s Humira (adalimumab) juggernaut continued as it not only remained the best-selling drug in the world, but also added another US$ 2 billion to its 2015 sales by generating record sales of US $16.078 billion in 2016.

Last year, the US Food and Drug Administration (FDA) approved Amgen’s Amjevita™ (adalimumab – atto) — a biosimilar of Humira®. Therefore, it remains to be seen if Humira will be able to sustain the momentum. Amjevita was approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis.

3. Epclusa (sofosbuvir and velpatasvir) – Gilead

2016 sales: US$ 1,752 million (new launch)

Gilead’s third sofosbuvir-based regimen — Epclusa (sofosbuvir and velpatasvir) was approved by the US FDA in June 2016. It is the first and only all-oral, pan-genotypic single tablet regimen for chronic Hepatitis C virus infection. While Epclusa registered an impressive start, Gilead’s other two sofosbuvir-based treatments — Sovaldi (sofosbuvir) and Harvoni (sofosbuvir and lepidasvir) — saw their combined sales decline by almost US$ 6 billion.

4. Imbruvica (ibrutinib) — Johnson & Johnson / AbbVie

2016 sales: US$ 3,083 million

2015 sales: US$ 1,443 million

Sales growth: US$ 1,640 million

Abbvie’s 2015 US$ 21 billion buy of Pharmacyclics seems to be paying off. The Pharmacyclics buy was a way to get access to Imbruvica (ibrutinib), a cancer drug which is co-marketed with Johnson & Johnson. It generated sales of US$ 3.083 billion in 2016. Imbruvica works by blocking a specific protein called Bruton’s tyrosine kinase (BTK). In December 2011, Johnson & Johnson said it would pay Pharmacyclics as much as US$ 975 million to fund getting the drug to market in exchange for half the profits generated globally.

5. Eliquis (apixaban) – Bristol-Myers Squibb / Pfizer

2016 sales: US$ 3,342 million

2015 sales: US$ 1,860 million

Sales growth: US$ 1,483 million

Although apixaban was the third-to-market novel oral anticoagulant (NOAC), which is co-promoted by Pfizer and Bristol-Myers Squibb as Eliquis, it continues to unseat Johnson & Johnson’s Xarelto (rivaroxaban) as the leader in its class based on total prescriptions. Rivaroxaban’s total 2016 sales were US$ 5.392 billion.

While Pfizer’s reports its sales as part of Alliance revenues, and exact sales are not known, Bristol-Myers Squibb results alone put Eliquis in the top 10 list. Generics are hot on their tail as, last month, Pfizer and Bristol-Myers’ filed suits against 16 generic makers to uphold their patents for apixaban.

6. Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) — Gilead

2016 sales: US$ 1,484 million

2015 sales: US$ 45 million

Sales growth: US$ 1,439 million

Genvoya has been the most successful HIV treatment launch since the introduction of Atripla (the first single-tablet regimen launched a decade ago). Gilead is the dominant HIV player in the US market and has the top three most-prescribed HIV regimens in the US.

Genvoya adds Tenofovir Alafenamide (TAF) to already known treatments. TAF based drugs have demonstrated a better safety profile. They would also allow Gilead to maintain its dominance in the HIV market.

7. Ibrance (palbociclib) — Pfizer

2016 sales: US$ 2,135 million

2015 sales: US$ 723 million

Sales growth: US$ 1,412 million

Discovered in Pfizer laboratories and approved by the US FDA in February 2015, Ibrance is used in combination with Letrozole as a first-line treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer.

8. Triumeq (abacavir, dolutegravir, lamivudine) – GlaxoSmithKline

2016 sales:US$ 2,151 million

2015 sales: US$ 905 million

Sales growth: US$ 1,246 million

GlaxoSmithKline’s HIV drugs business — ViiV Healthcare — has been enjoying sales growth with the introduction of Triumeq ® in its portfolio. While GSK is the major shareholder in ViiV Healthcare, Pfizer and Shionogi also have a stake. Triumeq® is the company’s first fixed-dose combination tablet for a once-daily single pill regimen that combines dolutegravir, an integrase inhibitor, with the nucleoside reverse transcriptase inhibitors — abacavir and lamivudine.

9. Revlimid (lenalidomide) – Celgene

2016 sales: US$ 6,974 million

2015 sales: US$ 5,801 million

Sales growth: US$ 1,173 million

Celgene’s Revlimid (lenalidomide) — a thalidomide-derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in US$ 5.8 billion in 2015, and grew another 20 percent this year, to US $6.974 billion. Revlimid now contributes more than 60 percent to Celgene’s total sales of US$ 11.229 billion.

10. Xarelto (rivaroxaban) – Johnson & Johnson (US) and Bayer

2016 sales: US$ 5,392 million

2015 sales: US$ 4,255 million

Sales growth: US$ 1,137 million

Bayer’s Xarelto, which is promoted by Johnson & Johnson in the United States, provided patients with an alternative to the old-guard therapy — warfarin. While rivaroxaban is competing with other novel oral anticoagulants (NOAC) like Eliquis (apixaban) and Pradaxa (dabigatran), rivaroxaban has the class lead in indications.

Xarelto recently posted positive results in a large-scale Phase 3 study —COMPASS, involving 27,402 patients, that assessed the effect of the blood thinner in preventing major adverse cardiac events (MACE).

The trial was stopped a year early on the advice of an independent Data Monitoring Committee, after the primary endpoint of prevention of MACE (which includes cardiovascular death, myocardial infarction and stroke) reached its pre-specified criteria for superiority over aspirin.

Our view

In QuintilesIMS Institute’s new annual drug spending report, analysts have forecasted that over the coming five years the industry should continue to receive 40 to 45 new drug approvals every year.

A quarter of all the drugs in late-stage development are now focused on oncology. The rate of oncology drug development has hit such a rapid pace that new drugs are superseding old ones in a matter of a few years.

It’s clear that this compilation will see radical changes next year. However, with eight out of the 10 fastest-selling drugs coming from chemical synthesis, traditional generic manufacturers still have a lot of opportunities to explore.


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FDA Approves Dorzolamide for Lowering Intraocular Pressure

FDA Approves Dorzolamide for Lowering Intraocular PressureIn late 2014 the FDA approved Dorzolamide Hydrochloride, to be used in conjunction with Timolol Maleate for the treatment of increased intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Known as the brand name eye drop Cosopt Opthamolic Solution, which is marketed by Lannett Company Inc., this solution has proven to be both safe and effectual. Dorzolamide Hydrochloride and Timolol Maleate is available in the newly approved 2%/0.5% opthamolic solution, and it is specifically indicated for patients who were insufficiently responsive to prior beta-blocker treatment. As an effective beta-adrenergic receptor blocking therapy, as well as a topical carbonic anhydrase inhibitor, the Dorzolamide and Timolol duo has proven to be a formidable opponent against elevated intraocular pressure.

One successful study of Dorzolamide and Timolol involved 1,035 patients who were diagnosed with elevated intraocular pressure alongside the diagnosis of either ocular hypertension or open-angle glaucoma. Discontinuation of the opthamolic solution occurred in only 5 percent of patients, who felt the adverse effects of a stinging sensation in the eyes and taste perversion were bothersome. However, the vast majority of patients who received Cosopt (Dorzolamide and Timolol) did not experience negative side effects causing them to withdraw from the study. The typical dosage for the Dorzolamide/Timolol therapy is one drop in each affected eye two times daily. It is advisable for patients to administer the drops as close to every 12 hours as possible. Contact lens wearers should avoid placing lenses in their eyes until at least ten minutes have passed after drop administration. Other eye drops that patients may use must also be administered at least 10 minutes after using Dorzolamide and Timolol. Commonly reported side effects include eye irritation, such as stinging or itchiness immediately after drop administration, as well as slight blurriness. These effects have proven to be mild and not noticeable throughout the day for the majority of patients.

Elevated intraocular pressure is a common symptom of open-angle glaucoma. As the number one cause of irreversible blindness both in the United States and around the globe, continued R&D is greatly needed for new therapies to treat the ever growing patient population suffering from glaucoma. Current data indicates that over 3 million Americans are living with a glaucoma diagnosis, with 2.7 million of these patients age 40 and older. The aging population worldwide has led to predictions of glaucoma cases to balloon to 80 million people by the year 2020.

LGM Pharma can assist clients as a supplier/distributor of Dorzolamide Hydrochloride CAS# 130693-82-2 and Timolol Maleate CAS# 26921-17-5 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Liraglutide FDA Approval Brings First Ever Injectable Weight Loss Drug

Liraglutide FDA Approved As 1st Ever Injectable Weight Loss DrugThe close of 2014 brought exciting news for Novo Nordisk’s innovative weight loss drug Saxenda. The Liraglutide FDA approval is the first of its kind as it’s the only available injectable treatment for obesity. The FDA overwhelmingly gave a nod to this easy to use form of Liraglutide as a safe and effectual option for patients suffering from obesity and in need of medical weight loss. Already approved in 2010 by the FDA for Type 2 Diabetes as the trade name Victoza, Liraglutide has proven to be an efficacious product aimed at combating the most common cause of diabetes worldwide. The newly approved Saxenda will contain a greater amount of Liraglutide than its initial product, Victoza, and it is designed to be an effective GLP-1 agonist that will promote weight loss and weight control.

The increase of obesity globally has become a serious and costly epidemic. Chronic management of obesity is called for, with treatments like Liraglutide considered to be a positive step in the right direction. As of 2015 one-third of adults in the United States are estimated to be classified as obese. The Liraglutide FDA approval of Saxenda (rDNA origin injection) is specifically endorsed as an adjunct treatment for chronic weight management alongside both increased physical activity and a healthy diet. Liraglutide works for weight control by sending a message of satiety to the center of the brain, which in turn slows down the stomach. Liraglutide has been documented in clinical trials to work exceptionally well at controlling hunger especially during the initial weeks of treatment, which naturally parlays to early weight loss and feelings of success amongst patients.

A landmark clinical trial which involved patients who were classified as obese but who were not diabetic showed an average yearly weight loss of 4.5 percent, as compared to a placebo. Approximately 49 percent of the patients who received Liraglutide as Saxenda lost at least 5 percent of their body weight. The dosage of Liraglutide is 3.0 milligrams per day, which is considerably higher than the dosing for patients with Type 2 Diabetes, which is between 1.2 milligrams and 1.8 milligrams daily. Adverse effects proved to be rare amongst trial participants. Common side effects reported were nausea and upset stomach, however no patient ended their participation due to these effects.

Another pivotal study, coined SCALE™, or Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic adults, proved to be noteworthy in the phase 3 clinical trial segment. Over 5,000 patients were enrolled in this trial, who were considered to be either obese or overweight. All patients exhibited various comorbidities associated with their condition. The use of Liraglutide for participants in this trial, combined with a reduced calorie diet and active exercise resulted in decidedly greater weight loss as compared to diet and exercise alone. Additionally, patients involved in the aforementioned study were able to gain control over weight related comorbid conditions, such as hypertension, high glycemic levels and dyslipidemia. Patients are advised to avoid the use of Liraglutide as Saxenda for weight control if they are currently using insulin, have or have had pancreatitis or are taking other products to promote weight loss.

LGM Pharma can assist clients as a supplier/distributor of the API Liraglutide, CAS # 204656-20-2, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Steady Growth Anticipated for Contrast Media Injectors like FDA Approved Iopamidol

FDA Approved LopamidolAn ongoing rise in imaging procedures, such as CT scans, PET scans, ultrasounds and MRIs has created a consistent demand for effectual contrast media injectors. Iopamidol has recently captured the attention of pharmaceutical research and development teams with an unprecedented FDA nod. At the close of November 2014 the FDA approved Iopamidol as a first and thus far only multi-dose compliant contrast medium. Designated as a breakthrough point-of care solution for usage in the CT Suite, the Iopamidol injection offers an innovative bulk pack design which minimizes adverse risk factors for patients. Additionally, the Iopamidol ISOVUE IBP presents consistently reliable safety standards, which lend to an effective and improved workflow for practitioners. Radiological procedures in the CT suite are performed across the globe at flourishing rates, leading to a swelling need for more efficacious contrast media products. A recent market research report released on January 5, 2015 predicts a steady increase in the need and utilization for contrast media injectors through 2020. The aforementioned report gleaned data from five major European markets and touted the increasing use of multi-dose contrast media worldwide.

Contrast Media DyeThe importance of quality imaging procedures has become a vital component of patient care. The FDA approval of Bracco’s ISOVUE IBP is the first nod to a technologically advanced form of contrast media. Advantages for practitioners utilizing this multi-dose and multi-patient contrast management system include the ability to control the amount of media via a precise injection and infusion rate, as well as greater patient safety via physician compliance. The current market for contrast media injectors, like Iopamidol, include the market application sub categories of cardiology, neurology and oncology. Products are segmented into CT, MR and angio/vascular injector categories. The Institute for Safe Medication Practices called for hospital pharmacy oversight in 2012 for the distribution, purchase, storage and use of intravenous contrast media, as well as the use of single dose vials and pre-filled syringes. The proper use of Pharmacy Bulk Packages, also known as PBPs, for radiological use was also stressed for continuous oversight and compliance by The Institute for Safe Medication Practices. The challenges facing a one size doesn’t fit all patient landscape is constantly being addressed by R&D experts in the contrast media field.

The Iopamidol ISOVUE IBP is praised for not only allowing cost-effective and targeted intravenous dosing, but also for offering 10-hour on-demand dosing from one container. Utilizing the same container for dosing eliminates the risk of multi-dose errors that are regularly associated with the transfer of contrast media outside of a hospital pharmacy setting. Future development of state of the art contrast media for improved Point-of-Care needs has become an anticipatory and prudent need around the globe. LGM Pharma can assist clients as a supplier/distributor of the API Iopamidol, CAS # 60166-93-0 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

FDA Approves Efficacious and Long-Acting MS Drug Alemtuzumab

FDA Approves Efficacious and Long-Acting MS Drug AlemtuzumabAlemtuzumab, also known as the brand name MS drug Lemtrada, has recently gained a long awaited FDA approval. Genzyme spent over a decade developing this long-acting agent designed to effectively treat patients with relapsing Multiple Sclerosis. The unique method of dispensing Alemtuzumab is a significant plus for patients who do not tolerate current medication regimens which involve monthly, weekly and even daily injections. Administration of Alemtuzumab is given via two infusion treatment courses, one for five days in a row and another course approximately twelve months later for three days straight. With sixty percent of the global market for MS in the United States the advent of this novel and innovative treatment option for patients is encouraging.

Two successful randomized Phase III trials led to the FDA nod of approval on November 14, 2014. These open-label studies compared Lemtrada to Rebif, which is a subcutaneous interferon beta-1a treatment, considered as high dose. The patients enrolled in these pivotal studies were all diagnosed with refractory MS, having had previously unsuccessful treatments, or patients who were new to any type of biologic treatments. The patient population with no prior medication regimen was deemed the CARE-MS I group and the study participants who had relapsed despite past medical interventions was coined CARE-MS II.

In the CARE-MS I study group the use of Alemtuzumab proved to work with much greater efficacy as compared to the clinical trial participants who were dosed with interferon beta-1a (Rebif). Positive findings in the group of patients who received Alemtuzumab included a notable reduction in yearly relapse rates and a statistically insignificant number of disability relapse rates.  Alemtuzumab was efficacious for the patients in the CARE-MS II study group as well, with participants experiencing a sizable reduction in relapse rates annually, as well as a slowed accumulation in disability overall. A total of 1,500 patients were involved in both studies, with over 6,400 years of patient assessment and follow-up. Alemtuzumab, or Lemtrada will be marketed with a warning for patients that include risks such as potential life-threatening infusion reactions, autoimmune conditions and a higher risk of cancers like thyroid cancer and melanoma. Initial access to this potent therapy will be reserved strictly for patients with relapsed and refractory MS. Sanofi representatives have indicated the current pricing for Lemtrada will be approximately $158,000 for a two treatment regimen.

Astounding figures have been revealed regarding the noted efficacy of Alemtuzumab, with roughly 70 percent of patients displaying no need for further treatments after the initial two for over three years’ time. Study analysts believe that the ability of Alemtuzumab to elicit relapse free results of up to five years’ time is clearly possible, if not probable. Side effects of Alemtuzumab include headache, nausea, rash, diarrhea, back pain, dizziness and insomnia. Serious adverse effects are rare, and may include thyroid disease and pneumonitis. Lemtrada was approved by the EU in September of 2013 and is currently approved in over forty countries worldwide. LGM Pharma can assist clients as a supplier/distributor of Alemtuzumab, CAS # 216503-57-0, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.